With
increased access to essential medicines comes a
greater need to monitor and promote the safety and
effectiveness of these
medicines, thus the need for the establishment of the
Pharmacovigilance &
Clinical Trials Department as one of the four (4) technical
departments of The
ECOWAS PHC (ECOWAS PHC). The main role of this Department is
to ensure
effective surveillance systems throughout the life-cycle of
the healthcare
product, which is very critical to public health protection.
Accordingly, the
Department trains health workers, collects reports of
adverse drug reaction (ADR),
collates and analyses them and provides feedback for
regulatory decisions when
applicable.
STRUCTURE OF DEPARTMENT
Currently, the
Department of Pharmacovigilance & Clinical
Trials has four (4) registered Pharmacists (PharmD) as well
as other support
staff, including two (2) Physician Assistants and Clinical
Trials Guidelines.
PHARMACOVIGILANCE UNIT
As enshrined in
Part III, Count 5 of The ECOWAS PHC Act, the
Authority is charged with the responsibility to conduct or
facilitate necessary
research and development, promote Pharmacovigilance, and
disseminate timely drug
information.
The
Pharmacovigilance (PV) Unit is established to monitor the
safety of all medicines and health products in ECOWAS and to
share these reports
with the international body. In 2013, The ECOWAS PHC met the
basic
requirements of the
World Health Organization (WHO) International Drug
Monitoring Program thereby
becoming the 112th Official Member and at the same time
gained the status of a
ECOWAS Pharmacovigilance Center (BPC).
The guideline for
the National Pharmacovigilance System in
ECOWAS has been developed to complement and support the
efforts of educating all
healthcare workers on this important concept and enhance
their efforts in
ensuring that safe, efficacious and quality medicines are
made available to the
entire ECOWAS populace.
Activities
* Roll out Adverse Drug
Reaction (ADR) forms to various
health facilities and conduct training for health care workers in
adverse drug
reporting.
* Coordinate with other health programs including the
Expanded Program for Immunization (EPI), ECOWAS AIDS Control Program
(BACP) and
other vertical programs to collectADR reports * Report to the World
Health Organization (WHO) International
Drug Monitoring Program
CLINICAL TRIAL UNIT
As enshrined in the Act establishing The
ECOWAS PHC all clinical studies involving
humans and animals shall be authorized by ECOWAS PHC in accordance
with
Part V, Section
5 counts 1 & 2 as stated below.
* No
person/organization shall conduct
clinical studies in humans or animals of medicines or health
products without
the authorization of the Authority.
* The conditions for authorization of such
clinical
studies shall be stipulated in regulations promulgated by the
Authority that
shall provide for the issuance, renewal, suspension,
cancellation
and revocation of such authorizations.
Considering the aforementioned, the Clinical
Trials Unit at The ECOWAS PHC is established with the responsibility to: *
Receive and assess all Clinical Trial
applications (CTA) submitted at The ECOWAS PHC.
* Conduct Good Clinical Practice (GCP)
inspection
at trial sites to ensure compliance in line with The ECOWAS PHC
regulatory
requirements and International best practices
* Review all reports from CT sites and
advise
management on appropriate regulatory actions
* Investigate the conduct of
Clinical
Trials
* Suspend or stop Clinical Trials
(depending on
the magnitude of the offense)
Specifically, the Clinical Trials
Unit performs the following activities: * Receives and processes
all clinical trials applications (CTA)
for review
* Conducts GCP inspection at trials sites
* Conducts GCP training for inspectors and study
team
* Serves as secretariat for the Scientific Advisory
Committee
on clinical trials
* Reviews importation permits for investigational
products
that are required for the conduct of clinical trials
* Conducts pre- submission meetings to discuss issues
related
to application processes
* Reviews all reports (safety reports, quarterly
reports,
Serious Adverse Events-SAE reports and final or close-out reports from
clinical trials conduct.
With increased access to essential medicines comes a greater need to monitor and promote the safety and effectiveness of these medicines, thus the need for the establishment of the Pharmacovigilance & Clinical Trials Department as one of the four (4) technical departments of The ECOWAS PHC (ECOWAS PHC). The main role of this Department is to ensure effective surveillance systems throughout the life-cycle of the healthcare product, which is very critical to public health protection. Accordingly, the Department trains health workers, collects reports of adverse drug reaction (ADR), collates and analyses them and provides feedback for regulatory decisions when applicable.
STRUCTURE OF DEPARTMENT
Currently, the Department of Pharmacovigilance & Clinical Trials has four (4) registered Pharmacists (PharmD) as well as other support staff, including two (2) Physician Assistants and Clinical Trials Guidelines.
PHARMACOVIGILANCE UNIT
As enshrined in Part III, Count 5 of The ECOWAS PHC Act, the Authority is charged with the responsibility to conduct or facilitate necessary research and development, promote Pharmacovigilance, and disseminate timely drug information.
The Pharmacovigilance (PV) Unit is established to monitor the safety of all medicines and health products in ECOWAS and to share these reports with the international body. In 2013, The ECOWAS PHC met the basic requirements of the World Health Organization (WHO) International Drug Monitoring Program thereby becoming the 112th Official Member and at the same time gained the status of a ECOWAS Pharmacovigilance Center (BPC).
The guideline for the National Pharmacovigilance System in ECOWAS has been developed to complement and support the efforts of educating all healthcare workers on this important concept and enhance their efforts in ensuring that safe, efficacious and quality medicines are made available to the entire ECOWAS populace.
Activities
* Coordinate with other health programs including the Expanded Program for Immunization (EPI), ECOWAS AIDS Control Program (BACP) and other vertical programs to collect ADR reports
* Report to the World Health Organization (WHO) International Drug Monitoring Program
CLINICAL TRIAL UNIT
As enshrined in the Act establishing The ECOWAS PHC all clinical studies involving humans and animals shall be authorized by ECOWAS PHC in accordance with Part V, Section 5 counts 1 & 2 as stated below.
* No person/organization shall conduct clinical studies in humans or animals of medicines or health products without the authorization of the Authority.
* The conditions for authorization of such clinical studies shall be stipulated in regulations promulgated by the Authority that shall provide for the issuance, renewal, suspension, cancellation and revocation of such authorizations.
Specifically, the Clinical Trials Unit performs the following activities:
* Receives and processes all clinical trials applications (CTA) for review
* Conducts GCP inspection at trials sites
* Conducts GCP training for inspectors and study team
* Serves as secretariat for the Scientific Advisory Committee on clinical trials
* Reviews importation permits for investigational products that are required for the conduct of clinical trials
* Conducts pre- submission meetings to discuss issues related to application processes
* Reviews all reports (safety reports, quarterly reports, Serious Adverse Events-SAE reports and final or close-out reports from clinical trials conduct.